Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 2:16 AM
Study NCT ID:
NCT07163260
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-10-24
First Post:
2025-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Defeat Rare Disease in Asia and Pacific (APAC) DRDA - Haemophilia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 244}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2025-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2025-08-06', 'studyFirstSubmitQcDate': '2025-09-02', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated prevalence of haemophilia', 'timeFrame': 'From start of data collection to end of data collection (approximately 5 months)', 'description': 'Proportion \\[%\\] of individuals in a population'}, {'measure': 'Estimated incidence of haemophilia', 'timeFrame': 'From start of data collection to end of data collection (approximately 5 months)', 'description': 'Number of new cases of haemophilia'}, {'measure': 'Estimated proportion of patients with haemophilia (PWH) who develop inhibitors (%)', 'timeFrame': 'From start of data collection to end of data collection (approximately 5 months)', 'description': 'proportion \\[%\\] of individuals in a population'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Haemophilia']}, 'descriptionModule': {'briefSummary': 'This study will help to better understand the course of disease in people with haemophilia (A or B \\[with or without inhibitors\\]) and the haemophilia care scenario in the selected countries and the experience so far in dealing with the condition. This is a survey-based study; hence no medications or other treatments will be provided to participants as a part of this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study will enroll 3 types of participant categories:\n\n1. Experienced/senior treating physicians i.e., haematologists, paediatric haematologist and physicians treating patients with haemophilia (PWH)\n2. Patient organisations (representatives of patient organisations), defined as the organisations working closely to support PWH at a national/regional level\n3. Patients/caregivers.', 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Experienced/Senior Treating Physicians\n\n* Experienced/senior haematologist treating haemophilia (adult or paediatric) or physician treating patients with haemophilia. (PWH), with greater than 5 years of experience.\n* Able to communicate in English or country specific language.\n* Agree/sign informed consent before data collection. For Patients Organisations\n* Patient organisation supporting haemophilia.\n* Expert having greater than 3 years of work experience with the patient organisation.\n* Expert level understanding of haemophilia landscape and care pathway in the relevant country.\n* Able to communicate in English or country specific language.\n* Agree/sign informed consent before data collection. For Patients/Caregivers\n\n 1. Patients of all age groups, diagnosed with haemophilia A or haemophilia B (with or without inhibitors) for greater than 2 years.\n 2. For patients less than 18 years of age (\\*less than 19 years for South Korea), their caregivers aged greater than or equal to 18 years (\\*greater than or equal to19 years for South Korea) should sign the informed consent.\n\n \\*For South Korea, the adult age is 19 years.\n 3. Able to communicate in English or country specific language.\n 4. Agree/sign informed consent before data collection.\n\n Exclusion Criteria:\n* There is no explicit exclusion criterion in this study, thus any participants group who answers "no" to any of the inclusion criteria will be excluded from the study.'}, 'identificationModule': {'nctId': 'NCT07163260', 'briefTitle': 'Defeat Rare Disease in Asia and Pacific (APAC) DRDA - Haemophilia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Defeat Rare Disease in Asia and Pacific (APAC) DRDA - Haemophilia', 'orgStudyIdInfo': {'id': 'DAS-8107'}, 'secondaryIdInfos': [{'id': 'U1111-1303-7372', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Experienced/Senior Treating Physicians', 'description': 'This group includes haematologists, paediatric haematologist and physicians treating patients with haemophilia (PWH)', 'interventionNames': ['Other: No treatment given']}, {'label': 'Patients Organisations', 'description': 'This group includes the organisations working closely to support patient with haemophillia (PWH) at a national/regional level', 'interventionNames': ['Other: No treatment given']}, {'label': 'Patients/Caregivers', 'description': 'This group includes patients with haemophilia and caregivers managing patients with haemophilia', 'interventionNames': ['Other: No treatment given']}], 'interventions': [{'name': 'No treatment given', 'type': 'OTHER', 'description': 'No treatment given', 'armGroupLabels': ['Experienced/Senior Treating Physicians', 'Patients Organisations', 'Patients/Caregivers']}]}, 'contactsLocationsModule': {'locations': [{'zip': '560 066', 'city': 'Bangalore', 'state': 'Karnataka', 'country': 'India', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}, {'zip': '50470', 'city': 'Kuala Lumpur', 'country': 'Malaysia', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 3.1412, 'lon': 101.68653}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'zip': '10500', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Novo Nordisk Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}